Purpose: To compare reusable and disposable flexible ureteroscopes in terms of efficacy and safety for patients undergoing Retrograde Intrarenal Surgery (RIRS). Patients and Methods: Patients with a renal stone eligible for RIRS were enrolled in this multicenter, randomized, clinical trial study. Patients were randomized into two groups: Group A (90 patients) underwent RIRS with a reusable flexible ureteroscope and group B (90 patients) were treated with a disposable one. Results: The patients’ demographics, stone features and pre-operative urine cultures were comparable between the groups. The Stone Free Rates (SFRs) were not significantly different (86.6% and 90.0% for group A and group B, respectively, p=0.11) and the mean cost for each procedure was comparable (2321 € in group A vs 2543 € in group B, p=0.09). However, the days of hospitalization and of antibiotic therapy were higher in group A (p ≤ 0.05). The overall complication rate in group A was 8.8% whilst in group B it was 3.3% (p ≤ 0.05); in particular, group A exhibited a greater number of major complications (Clavien score IIIa-V). The overall postoperative infection rate was 16.6% in group A and 3.3% in group B (p ≤ 0.05). Furthermore, none of the patients in group B developed urosepsis or had a positive blood culture, while 3 patients in group A did (p<0.05). Conclusion: The use of disposable ureteroscopes is characterized by significantly lower post-operative complications and infection rates, while having comparable costs and SFRs vis à vis reusable ureteroscopes. Clinical Trial Registration Number: ISRCTN92289221.
Disposable versus reusable ureteroscopes: A prospective multicenter randomized comparison / Bozzini, G.; Filippi, B.; Alriyalat, S.; Calori, A.; Besana, U.; Mueller, A.; Pushkar, D.; Romero-Otero, J.; Pastore, A.; Sighinolfi, M. C.; Micali, S.; Buizza, C.; Rocco, B.. - In: RESEARCH AND REPORTS IN UROLOGY. - ISSN 2253-2447. - 13:(2021), pp. 63-71. [10.2147/RRU.S277049]
Disposable versus reusable ureteroscopes: A prospective multicenter randomized comparison
Bozzini G.;Filippi B.;Sighinolfi M. C.;Micali S.;Rocco B.
2021
Abstract
Purpose: To compare reusable and disposable flexible ureteroscopes in terms of efficacy and safety for patients undergoing Retrograde Intrarenal Surgery (RIRS). Patients and Methods: Patients with a renal stone eligible for RIRS were enrolled in this multicenter, randomized, clinical trial study. Patients were randomized into two groups: Group A (90 patients) underwent RIRS with a reusable flexible ureteroscope and group B (90 patients) were treated with a disposable one. Results: The patients’ demographics, stone features and pre-operative urine cultures were comparable between the groups. The Stone Free Rates (SFRs) were not significantly different (86.6% and 90.0% for group A and group B, respectively, p=0.11) and the mean cost for each procedure was comparable (2321 € in group A vs 2543 € in group B, p=0.09). However, the days of hospitalization and of antibiotic therapy were higher in group A (p ≤ 0.05). The overall complication rate in group A was 8.8% whilst in group B it was 3.3% (p ≤ 0.05); in particular, group A exhibited a greater number of major complications (Clavien score IIIa-V). The overall postoperative infection rate was 16.6% in group A and 3.3% in group B (p ≤ 0.05). Furthermore, none of the patients in group B developed urosepsis or had a positive blood culture, while 3 patients in group A did (p<0.05). Conclusion: The use of disposable ureteroscopes is characterized by significantly lower post-operative complications and infection rates, while having comparable costs and SFRs vis à vis reusable ureteroscopes. Clinical Trial Registration Number: ISRCTN92289221.File | Dimensione | Formato | |
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